Skip to main content

Renewal and Periodic Re-Inspection

KGMP certificate validityโ€‹

KGMP certificates have a validity period of approximately 3 years. Renewal application must be submitted before expiry.

Renewal processโ€‹

  1. Submit renewal application via MFDS eSubmission portal before expiry
  2. MFDS schedules a periodic re-inspection
  3. Re-inspection may be lighter than initial certification if quality record is good

Periodic surveillance inspectionsโ€‹

MFDS may conduct unannounced or scheduled surveillance inspections at any time during the certificate validity period.

Lapsed certification consequencesโ€‹

  • Cannot supply new products to the Korean market
  • Existing supply chain stock: short transition period may apply
  • MFDS may suspend or cancel associated ํ’ˆ๋ชฉํ—ˆ๊ฐ€